ASTM F2255-24

ASTM F2255-24

Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading

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1.1 This test method is intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices.

1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Significance and Use:

4.1 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient-specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.

4.2 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure), is such that the results of a single lap-shear test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors.

4.3 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.

Additional Info

Author American Society for Testing and Materials (ASTM International)
Committee F04.15 - Committee F04 on Medical and Surgical Materials and Devices
Published by ASTM
Document type Standard
Theme Textiles in general,Adhesives
ICS 59.080.01 : Textiles in general
83.180 : Adhesives
Number of pages 6
Replace ASTM F2255-05(2015)
Keyword F2255

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